BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2232895 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06437
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 12/18/2012 DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: ON EXAMINATION, THERE WAS A CRACK IN THE BATTERY COMPARTMENT AND THE BATTERY COMPARTMENT THREADS WERE STRIPPED. THE BATTERY CAP THAT WAS RETURNED WITH THE PUMP FOR INVESTIGATION COULD NOT MAINTAIN AN ELECTRICAL CONNECTION WHEN PLACE ON THE PUMP CAUSING POWER LOSS AND REBOOTING. THE BATTERY CAP WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. A TEST BATTERY CAP WAS USED FOR TESTING. WITH THE TEST BATTERY CAP SECURELY IN PLACE, THE PUMP POWERED ON PROPERLY. THE PUMP WAS EXERCISED FOR 24 HOURS USING THE TEST CAP WITH NO FURTHER POWER INTERRUPTIONS.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP WOULD NOT POWER ON AFTER A ROUTINE BATTERY CHANGE. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR